Efficacy and Safety of Mexartan Potassium Tablets (AZL-M) and Calcium Channel Blockers (CCB) in the Treatment of Adults With Essential Hypertension in Chinese Population: a National Multicenter, Prospective, Observational Study

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Observational
SUMMARY

This is a national multicenter, prospective, observational study. It is planned to enroll 1215 patients with newly diagnosed essential hypertension in 80 centers, and divide them into 3 groups according to different treatment plans given by doctors: AZL-M monotherapy group, CCB monotherapy group (amlodipine besylate tablets or nifedipine controlled-release tablets) and AZL-M+CCB (amlodipine besylate tablets or nifedipine controlled-release tablets) combined treatment group. Subjects were visited 4 times at baseline, 1 month, 3 months, and 6 months, and the following key indicators of subjects were measured according to the doctor's decision, and the measurement results were collected

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Age ≥ 18 years old (one year old);

• Patients diagnosed with essential hypertension;

• Did not receive any antihypertensive drug treatment for at least 3 months before enrollment;

• Eligible to use 80 mg once-daily AZL-M at baseline or CCB (amlodipine besylate tablets or nifedipine controlled-release tablets) or CCB (besylate Amlodipine tablets or nifedipine controlled-release tablets) + AZL-M 80 mg once-daily combination therapy; Volunteer to participate in this study, understand and sign the written informed consent.

Locations
Other Locations
China
Junbo Ge
RECRUITING
Shanghai
Contact Information
Primary
Jun Bo Ge, academician
ge.junbo@zs-hospital.sh.cn
+86 13901977506
Time Frame
Start Date: 2024-01-22
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 1215
Treatments
AZL-M single drug group
Azilsartan Medoxomil Potassium Tablet,80mg,tablet,QD,six months
CCB single drug group
Nifedipine Controller-release Tablets,clinical maximum tolerated dose,tablet,QD,six months;or Levoamlodipine Maleate Table,clinical maximum tolerated dose,tablet,QD,six months; Doctor choose a medication that is more suitable for patient treatment.
AZL-M + CCB drug group(Combined medication)
Nifedipine Controller-release Tablets,clinical maximum tolerated dose,tablet,QD,six months;and Levoamlodipine Maleate Table,clinical maximum tolerated dose,tablet,QD,six months; When the patient's upper pressure exceeds 160 Millimetre of mercury, the doctor will choose combination medication .CCB drug will be chosen either Nifedipine Controller-release Tablets or Levoamlodipine Maleate Table.
Related Therapeutic Areas
Sponsors
Leads: Hasten Biopharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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